MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Pyrosis/Heartburn (1883)

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported that patient received mri on (b)(6) 2023, they felt a pop and on x-ray they revealed it was discontinuous.They are unsure if it was from the mri or not.There is no scheduled explant date set yet for the device.

Manufacturer Narrative

(b)(4).Date sent: 1/18/2024 b3: only event year known: 2024 no lot number was provided therefore a device history could not be done.Additional information received; date of implant : working with different hospital to get the date of surgery date of mri: (b)(6) 2023 date of any return of symptoms:(b)(6) 2023 ¿when i was in the machine i started to have chest pain and i felt a "pop" in the epigastric area.¿ ¿i did an xray and the device is broken.Unsure if it was broke before the mri or not.¿ patient age, gender, bmi, general health, allergies: 46 y.O female.Allergies to amoxicillin.Per communication with patient:¿ notified patient who stated she would like to wait and see how she feels and if gerd/heartburn becomes an issues again, but will call office to schedule an ov if issues are persistent or if she notices any changes.¿ however, i did update her with the following information that you shared should she choose to have it replaced.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what was the mri strength? what is the product code? what was the date of implant? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: productcompliant1@its.Jnj.Com what is the device lot number? was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 2/5/2024 additional information was requested, and the following was obtained: what was the mri strength? 1.5t.What is the product code? na.What was the date of implant? na.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: (b)(4).What is the device lot number? na.Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? no.Did the patient have any other surgeries in the area? no.Was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.Na.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? the patient is not requesting it to be removed- gerd symptoms still being managed.When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? no removal at this time.When and if the linx device is removed, may we ask that the device be returned for analysis? if it¿s ever remvoed the surgeon will proved the device.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18538420
• MDR Text Key: 333172191
• Report Number: 3008766073-2024-00012
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female